Treatment of therapy resistant Alopecia areata with fumaric acid esters (Fumaderm® and Fumaderm initial®) – an open, single center, non-randomized, pilot study with 40 patients - AAF-Trial

niversity Hospital Tübingen0 个研究点开始时间: 2011年6月28日最近更新: 2012年7月3日

适应症

试验速览

暂无简介。

•18 to 65 years of age; Able to give a free, informed consent; Diagnosis of chronic, moderate to severe scalp AA, defined as = 20% AA, with a hair loss of at least 6 months' duration; Signed and dated informed consent before the start of specific protocol procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with alopecia totalis, alopecia universalis, or coexisting significant androgenetic alopecia (Norwood-Hamilton stage IV or greater in males, Ludwig stage III in females); Systemic therapies (corticosteroids, fumaric acid derivatives, cyclosporine A, methotrexate, biologic medications, retinoids, azathioprine) and phototherapy (UV-B, PUVA) have to be discontinued for = 1 month prior to and during the entire study treatment period; Topical therapies (corticosteroids, contact sensitizing agents, tacrolimus, or pimecrolimus) have to be discontinued for = 2 weeks prior to and during the entire study treatment period; Pregnant or breastfeeding patients
•Severe gastrointestinal diseases (Ulcus ventriculi or Ulcus duodeni), kidney disease (creatine clearence > 1.3 mg/dl), severe liver disease (liver enzymes > 2 times maximum of normal range), leucopenia (lympocyte counts < 500 cells / mm²); known allergy against DMF or one of the other components of Fumaderm®/Fumaderm initial®

发起方

niversity Hospital Tübingen